1. NAME OF THE MEDICINAL PRODUCT
Bisacodyl Gastro-resistant Tablets 5mg Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains

Bisacodyl USP     5mg
Excipients        q.s.

For excipients, see 6.1

3. PHARMACEUTICAL FORM
Gastro-resistant tablets for oral administration.
Circular, biconvex, yellow, sugar-coated and enteric-coated tablet.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Short term relief of constipation.

4.2  Posology and method of administration
Adults and children over 10 years: 1 to 2 coated tablets (5-10 mg) daily before bedtime.
It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum daily dose should not be exceeded.

In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped.

It is recommended to take the coated tablets at night to have a bowel movement the following morning. They should be swallowed whole with an adequate amount of fluid.

The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

4.3 Contraindications
Bisacodyl is contraindicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned severe conditions.

Bisacodyl is also contraindicated in severe dehydration and in patients with Known hypersensitivity to bisacodyl or any other component of the product.

In case of hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and special precautions for use” the use of the product is contraindicated.

4.4 Special Warnings and precautions for use
As with all laxatives, Bisacodyl should not be taken on a continuous daily basis for more than five days without investigating the cause of constipation.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.

Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) BISACODYL should be discontinued and only be restarted under medical supervision.

Stimulant laxatives including Bisacodyl do not help with weight loss (see section 5.1 Pharmacodynamic properties).

Patients may experience haematochezia (blood in stool) that is generally mild and self-limiting.

Dizziness and / or syncope have been reported in patients who have taken Bisacodyl. The details available for these cases suggest that the events would be consistent with defaecation syncope (or syncope attributable to straining at stool), or with a vasovagal response to abdominal pain related to the constipation, and not necessarily to the administration of bisacodyl itself.

There have been isolated reports of abdominal pain and bloody diarrhoea occurring after taking bisacodyl. Some cases have been shown to be associated with colonic mucosal ischaemia.

Bisacodyl Tablets contain a small amount of lactose (33.2 mg) and sucrose (23.4 mg) in each tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction
The concomitant use of antacids and milk products may reduce the resistance of the coating of the tablets and result in dyspepsia and gastric irritation.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses of Bisacodyl are taken.

Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides.

The concomitant use of other laxatives may enhance the gastrointestinal side effects of Bisacodyl.

4.6 Fertility, Pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. Long experience has shown no evidence of undesirable or damaging effects during pregnancy.

Clinical data show that neither the active moiety of bisacodyl (BHPM or bis- (p-hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Nevertheless, as with all medicines, Bisacodyl should not be taken in pregnancy, especially the first trimester, and during breast feeding unless the expected benefit is thought to outweigh any possible risk and only on medical advice.

No studies on the effect on human fertility have been conducted.

4.7 Effects on ability to drive and use machines
No studies on the effects of Bisacodyl on the ability to drive and use machines have been performed.

However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and / or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.

4.8 Undesirable Effects
The most commonly reported adverse reactions during treatment are abdominal pain and diarrhoea.

Adverse events have been ranked under headings of frequency using the following convention: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000).

Immune system disorders

Rare: anaphylactic reactions, angioedema, hypersensitivity.

Metabolism and nutrition disorders

Rare: dehydration.

Nervous system disorders

Uncommon: dizziness.

Rare: Syncope.

Dizziness and syncope occurring after taking bisacodyl appear to be consistent with a vasovagal response (e.g. to abdominal spasm, defaecation).

Gastrointestinal disorders

Uncommon: haematochezia (blood in stool), vomiting, abdominal discomfort, anorectal discomfort.

Common: abdominal cramps, abdominal pain, diarrhoea and nausea.

Rare: colitis including ischaemic colitis.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product.

4.9 Overdose
Symptoms
If high doses are taken watery stools (diarrhoea), abdominal cramps and a clinically significant loss of fluid, potassium and other electrolytes can occur.

Laxatives when taken in chronic overdose may cause chronic diarrhoea, abdominal pain, hypokalaemia, secondary hyperaldosteronism and renal calculi. Renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described in association with chronic laxative abuse.

Therapy

After ingestion of oral forms of Bisacodyl, absorption can be minimised or prevented by inducing vomiting or gastric lavage. Replacement of fluids and correction of electrolyte imbalance may be required. This is especially important in the elderly and the young. Administration of antispasmodics may be of value.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis with promotion of accumulation of water, and consequently electrolytes, in the colonic lumen. This results in a stimulation of defecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established.

As a laxative that acts on the colon, bisacodyl specifically stimulates the natural Evacuation process in the lower region of the gastrointestinal tract. Therefore, bisacodyl is ineffective in altering the digestion or absorption of calories or essential nutrients in the small intestine.

 5.2 Pharmacokinetic properties
Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), mainly by esterases of the enteric mucosa.

Administration as an enteric coated tablet was found to result in maximum BHPM plasma concentrations between 4 – 10 hours post administration whereas the laxative effect occurred between 6 – 12 hours post administration. In contrast, following the administration as a suppository, the laxative effect occurred on average approximately 20 minutes post administration; in some cases it occurred 45 minutes after administration. The maximum BHPM- plasma concentrations were achieved 0.5 – 3 hours following the administration as a suppository. Hence, the laxative effect of bisacodyl does not correlate with the plasma level of BHPM. Instead, BHPM acts locally in the lower part of the intestine and there is no relationship between the laxative effect and plasma levels of the active moiety. For this reason, bisacodyl coated tablets are formulated to be resistant to gastric and small intestinal juice. This results in a main release of the drug in the colon, which is the desired site of action.

After oral and rectal administration, only small amounts of the drug are absorbed and are almost completely conjugated in the intestinal wall and the liver to form the inactive BHPM glucuronide. The plasma elimination half-life of BHPM glucuronide was estimated to be approximately 16.5 hours. Following the administration of bisacodyl coated tablets, an average of 51.8% of the dose was recovered in the faeces as free BHPM and an average of 10.5% of the dose was recovered in the urine as BHPM glucuronide. Following the administration as a suppository, an average of 3.1% of the dose was recovered as BHPM glucuronide in the urine. Stool contained large amounts of BHPM (90% of the total excretion) in addition to small amounts of unchanged bisacodyl.

5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Tablet core:
Lactose
Maize starch
Soluble maize starch
Glycerol
Magnesium stearate

Tablet coating:
Magnesium stearate
Sucrose
Talc
Acacia
Titanium dioxide (E171)
Methacrylic acid-methylmethacrylate copolymer (1:1)
Methacrylic acid-methylmethacrylate copolymer (1:2)
Castor oil
Macrogol 6000
Yellow iron oxide (E172)
White beeswax
Carnauba wax
Shellac.

6.2 Incompatibilities
None known.

6.3  Shelf life
3 years

6.4 Special precautions for storage
Do not store above 25°C.
Keep container in the outer carton.

6.5 Nature and contents of container
Blister packs consisting of opaque white PVC/PVDC blister foil and aluminium foil (covering foil).
Blister packs consisting of colourless PVC blister foil and aluminium foil (covering foil).
Packs of 6, 8, 10, 20, 30, 40 and 60.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
None stated.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Bisacodyl Gastro-resistant Tablets 5 mg Taj Pharma

Package leaflet: Information for the patient

Bisacodyl Gastro-resistant Tablets 5 mg Taj Pharma.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Bisacodyl is and what it is used for
2. Before you are given Bisacodyl
3. How you will be given  Bisacodyl
4. Possible side effects
5. How Bisacodyl is stored
6. Further Information

1. What Bisacodyl is and what it is used for
• Bisacodyl 5mg Gastro-resistant tablets contain a medicine called bisacodyl. This belongs to a group of medicines called laxatives.
• Bisacodyl is used for the short-term relief from occasional constipation.
• Bisacodyl can also be used in a hospital to empty a person’s bowel before child birth, surgery or radiological investigations.
• Bisacodyl gently stimulate the muscles of the bowel (large intestine). This brings predictable, overnight relief from constipation.
• Bisacodyl 5mg Gastro-resistant Tablets have a special coating that helps to ensure the medicine works only where it is needed.
• Bisacodyl 5mg Gastro-resistant Tablets do not help with weight loss.

What is constipation?
Normal and regular bowel movement is important for most people. However, what is ‘normal and regular’ varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern.
• Constipation is an occasional problem for some people. For others, it may happen more often.
• It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body.

The cause of constipation is often not known. It can be associated with:
• Sudden change of diet
• A diet with not enough fibre
• Loss of ‘tone’ in the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally ‘off colour’. Sometimes it causes headaches.

These healthy tips are recommended to try to prevent constipation happening:
• Eat a balanced diet including fresh fruit and vegetables.
• Drink enough water so that you do not become dehydrated.
• Keep up your exercise and stay fit.
• Make time to empty your bowel when your body tells you.

2. Before you are given Bisacodyl
Do not take Bisacodyl if:
• You are allergic to bisacodyl or any of the other ingredients in this medicine. (listed in Section 6).
• You are intolerant to or cannot digest some sugars (as the tablet contains a small amount of lactose and sucrose).
• You have severe dehydration.
• You have a bowel condition called ‘ileus’ (blockage in the intestine).
• You have a serious abdominal condition such as appendicitis.
• You have severe abdominal pain with nausea and vomiting.
• You have a blocked bowel (intestinal obstruction).
• You have inflammation of the bowel (small or large intestine).

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisacodyl

Other medicines and Bisacodyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Bisacodyl can affect the way some other medicines work. Also, some other medicines can affect the way Bisacodyl works.

In particular, tell your doctor or pharmacist if you are taking:
• water tablets (diuretics)such as bendrofluazide or furosemide (frusemide)
• steroid medicines such as prednisolone
• Other laxative medicines

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Bisacodyl 5mg Gastro-resistant Tablets.

Pregnancy and breast feeding
Talk to your doctor or pharmacist before taking Bisacodyl if you are pregnant, planning to become pregnant or are breast feeding.

Driving and using machines
Some people may feel dizzy or faint while taking this medicine. If this happens to you, wait until these feelings go away before driving or using machines.

Bisacodyl contains Lactose, Sucrose and Tartrazine
This medicine contains lactose (a milk sugar) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The tablets also contain Tartrazine (E102) which may cause allergic reactions.

3. How you will be given Bisacodyl
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

As with all laxatives, Bisacodyl should not be taken every day for more than five days. If you need laxatives every day, or if you have abdominal pain which does not go away, you should see your doctor.

Taking this medicine:
• Swallow the tablets whole with water.
• Milk, antacids or proton pump inhibitors (medicines which reduce stomach acid) should not be taken within one hour before or after taking Bisacodyl. This is because they will stop Bisacodyl from working properly.

How much to take
Adults and children over 10 years old
• Take one or two tablets (5 to 10 mg) daily before bedtime.
• If you have not taken Bisacodyl 5mg Gastro-resistant Tablets before, start with one tablet and increase to two if necessary.
• When your bowel regularity has returned to normal, the dose can usually be stopped.

Children aged between 4 and 10 years
Bisacodyl 5mg Gastro-resistant Tablets should only be given to children between the ages of 4 and 10 if recommended by a doctor. The usual dose for children is:
• one tablet (5 mg) daily before bedtime.

Children under 4 years
Bisacodyl 5mg Gastro-resistant Tablets are not recommended for children under 4 years.

If you take more Bisacodyl than you should
It may be harmful to:
• take too much bisacodyl
• take bisacodyl for too long

This is because taking too much for too long may lead to:
• Imbalance of fluid and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood.
• Low levels of potassium in the blood (called ‘hypo-kalaemia’). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.
• Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean you cannot pass enough urine.

If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you; this is so the doctor knows what you have taken.

If you forget to take Bisacodyl
If you have forgotten to take your tablet at night, wait for the next dose and continue as before. Do not take any more tablets in one day than your doctor has prescribed. Do not take a double dose to make up for a missed dose.
If you feel that the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, Bisacodyl can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Rare side effects (affect less than 1 in 1000 people)
• Severe allergic reactions which may cause swelling of the face or throat and difficulty in breathing or dizziness. If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away.
• Colitis (inflammation of the large intestine which causes abdominal pain and diarrhea)
• Dehydration
• Allergic reactions which may cause a skin rash
• Fainting

Uncommon side effects (affect less than 1 in 100 people)
• Blood in the stools
• Vomiting
• Abdominal discomfort
• Discomfort inside and around the back passage
• Dizziness

Common side effects (affect less than 1 in 10 people):
• Abdominal cramps or pain
• Diarrhoea
• Nausea

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Bisacodyl is stored
Keep this medicine out of the sight and reach of children.
Do not use Bisacodyl after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container.
Keep the container tightly closed (for polypropylene containers only).
Do not use Bisacodyl if you notice any deterioration or damage to the outer packaging
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help protect the environment.

6. Further information

What Bisacodyl contains
• The active substance is Bisacodyl.
Each tablet contains: Bisacodyl USP   5mg
The other ingredients are:
Core Tablet: Lactose monohydrate, Liquid paraffin, Maize starch and Magnesium stearate.
Enteric Coating: Methacrylic acid Co-Polymer Ethyl Acrylate Co Polymer (1:1) dispersion 30% material, Macrogol 3350, Talc and Simethicone PD30. Sugar Coat; Povidone K30, Talc, Kaolin light and Sucrose. Colour Coat; Titanium dioxide (E171) and Tartrazine lake (E102). Polishing; Carnauba wax.

What Bisacodyl looks like and contents of the pack
Bisacodyl are yellow shiny biconvex sugar coated gastro resistant tablets.
Bisacodyl 5mg, gastro-resistant tablets are available in blister packs (cartons) of 20, 60 and 100 tablets and in polypropylene containers of 500 and 1000 tablets.
Not all pack sizes may be marketed.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com